2016 – Federal Register Recent Federal Regulation Documents
Results 3,601 - 3,650 of 31,152
Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved Collection: National Clandestine Laboratory Seizure Report
The Department of Justice (DOJ), Drug Enforcement Administration, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This collection was previously published in the Federal Register at 81 FR 63224, on September, 14, 2016, allowing for a 60 day comment period.
Government-Industry Advisory Panel; Notice of Federal Advisory Committee Meeting
The Department of Defense is publishing this notice to announce the following Federal advisory committee meeting of the Government-Industry Advisory Panel. This meeting is open to the public.
Temporary General License: Extension of Validity
On March 24, 2016, the Bureau of Industry and Security (BIS) published a final rule, Temporary General License. The March 24 final rule created a temporary general license that restored, for a specified time period, the licensing requirements and policies under the Export Administration Regulations (EAR) for exports, reexports, and transfers (in-country) as of March 7, 2016, to two entities (ZTE Corporation and ZTE Kangxun) that were added to the Entity List on March 8, 2016. At this time, the U.S. Government has decided to extend the temporary general license until February 27, 2017. In order to implement this decision, this final rule revises the temporary general license to remove the expiration date of November 28, 2016, and to substitute the date of February 27, 2017. This final rule makes no other changes to the EAR.
Government-Owned Inventions; Availability for Licensing and/or Co-Development
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. to achieve expeditious commercialization of results of federally- funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.
Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates; Guidance for Industry.'' The guidance document provides establishments that make donor eligibility (DE) determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) with information on infectious-disease risks related to receipt of FDA licensed human-derived clotting factor concentrates (HDCFCs). The guidance explains that FDA no longer considers FDA licensed HDCFCs as a risk factor for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV). As such, receipt of FDA licensed HDCFCs, or sex with a person who has received FDA licensed HDCFCs, should not be considered a risk factor when determining eligibility of a donor of HCT/Ps. The guidance supplements the recommendations regarding HDCFCs that are contained in the guidance entitled ``Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry'' dated August 2007.
Incidental Take Permit Applications for Alabama Beach Mouse; Gulf Shores, Alabama
Under the Endangered Species Act, we, the U.S. Fish and Wildlife Service, announce the receipt and availability of three proposed low-effect habitat conservation plans and accompanying incidental take permit applications for take of Alabama beach mouse habitat incidental to construction in Orange Beach and Gulf Shores, Alabama. We invite public comments on these documents.
Filing of Plats of Survey; NV
The purpose of this notice is to inform the public and interested State and local government officials of the filing of Plats of Survey in Nevada.
Filing of Plats of Survey: Oregon/Washington
The plats of survey of the following described lands are scheduled to be officially filed in the Bureau of Land Management, Oregon State Office, Portland, Oregon, 30 days from the date of this publication.
Bacillus Calmette-Guerin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment; Draft Guidance for Industry; Availability
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Bacillus Calmette-Guerin (BCG)Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment.'' The purpose of this guidance is to assist sponsors in the development of drugs and biologics to treat patients with a high-risk form of bladder cancer. The alternative is radical cystectomy, a surgical procedure with significant morbidity and mortality. This guidance will help overcome some of the obstacles in conducting the studies needed to establish efficacy of drugs and biologics for these patients with an unmet medical need.
Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of guidance for industry entitled ``Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments.'' This guidance provides updated answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding GDUFA user fees and finalizes the revised version of the guidance.
Maritime Environmental and Technical Assistance (META) Program Workshop on Battery Applications in Maritime Transportation
The Maritime Administration (MARAD), in cooperation with Det Norske Veritas-Germanischer Lloyd, American Bureau of Shipping, and The American Society for Testing and Materials, will hold a workshop to share information and gather input related to the application of high- power batteries in maritime transportation. The workshop is being held as part of the Agency's Maritime Environmental and Technical Assistance (META) Program. Information received during the workshop will be used to enhance Agency and maritime industry stakeholders' understanding of the state of technology, potential design requirements for electric powered and hybrid electric vessels, and areas for future research, development and demonstration projects.
Sanctions Actions Pursuant to Executive Order 13660
The Treasury Department's Office of Foreign Assets Control (OFAC) is publishing the names of six persons whose property and interests in property are blocked pursuant to Executive Order (E.O.) 13660.
Fair Credit Reporting Act Disclosures
The Bureau of Consumer Financial Protection (Bureau) announces that the ceiling on allowable charges under section 612(f) of the Fair Credit Reporting Act (FCRA) will remain unchanged at $12.00, effective for 2017. The Bureau is required to increase the $8.00 amount referred to in section 612(f)(1)(A)(i) of the FCRA on January 1 of each year, based proportionally on changes in the Consumer Price Index for All Urban Consumers (CPI-U), with fractional changes rounded to the nearest fifty cents. The CPI-U increased 49.77 percent between September 1997, when the FCRA amendments took effect, and September 2016. This increase in the CPI-U, and the requirement that any increase be rounded to the nearest fifty cents, result in a maximum allowable charge of $12.00.
Notice of Solicitation of Applications (NOSA) Inviting Applications for the Rural Business Development Grant Program To Provide Technical Assistance for Rural Transportation Systems
This Notice is to invite applications for grants to provide Technical Assistance for Rural Transportation (RT) systems under the Rural Business Development Grant (RBDG) program pursuant to 7 CFR part 4280, subpart E, 2 CFR chapter IV and 2 CFR part 200 for fiscal year (FY) 2017, subject to the availability of funding to provide Technical Assistance for RT systems and for RT systems to Federally Recognized Native American Tribes' (FRNAT) (collectively ``Programs'') and the terms provided in such funding. This Notice is being issued before the FY 2017 appropriation has been enacted in order to allow applicants sufficient time to leverage financing, prepare and submit their applications, and give the Agency time to process applications in FY 2017. This Notice is based on the assumption that the FY 2017 appropriation will be identical to its successors. Should that not be the case, this Notice will be amended to reflect those changes. Successful applications will be selected by the Agency for funding and subsequently awarded to the extent that funding may ultimately be made available to the Agency through appropriations. Awards under both grant Programs will be competitively awarded to eligible applicant(s) which historically has been a qualified national Nonprofit organization. It is expected that one grant will be for the provision of Technical Assistance to RT Projects and that the other grant will be for the provision of Technical Assistance to RT Projects operated by FRNATs only. All applicants are responsible for any expenses incurred in developing their applications. All initially capitalized terms in this Notice, other than proper names, are defined in 7 CFR 4280.403.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements
This document corrects technical errors in the final rule that was placed on public inspection at the Office of the Federal Register on November 2, 2016 and scheduled for publication in the Federal Register on November 15, 2016. That rule is entitled, ``Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements.''
Notice of Temporary Concession Contracts for Certain Visitor Services in Acadia National Park
The National Park Service intends to award two temporary concession contracts to a qualified person for the conduct of certain visitor services within Acadia National Park for a term not to exceed 3 years. The visitor services include guided bus tours.
Applications for Licensing as a Non-Leveraged Rural Business Investment Company Under the Rural Business Investment Program
This Notice announces the acceptance of applications from newly-formed Rural Business Investment Companies (RBICs) or new funds from existing RBICs who are interested in obtaining a licensed fund as non-leveraged RBICs under the Agency's Rural Business Investment Program (RBIP).
Thirteenth RTCA SC-228 Focused Plenary
The FAA is issuing this notice to advise the public of a meeting of Thirteenth RTCA SC-228 Focused Plenary.
Agency Information Collection Activities: Record of Vessel Foreign Repair or Equipment Purchase
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Record of Vessel Foreign Repair or Equipment Purchase (CBP Form 226). CBP is proposing that this information collection be extended with no change to the burden hours or to the information collected. This document is published to obtain comments from the public and affected agencies.
Notice of Continuation of Concession Contracts
Pursuant to the terms of existing concession contracts, public notice is hereby given that the National Park Service intends to request a continuation of visitor services for a period not to exceed one year.
Notice of Extension of Concession Contracts
The National Park Service hereby gives public notice that it proposes to extend the expiring concession contracts listed below for the period specified, or until the effective date of a new contract, whichever occurs sooner.
Forty Sixth RTCA SC-206 Aeronautical Information and Meteorological Data Link Services Plenary
The FAA is issuing this notice to advise the public of a meeting of Forty Sixth RTCA SC-206 Aeronautical Information and Meteorological Data Link Services Plenary.
Forty Fifth RTCA SC-224 Airport Security Access Control Systems Plenary
The FAA is issuing this notice to advise the public of a meeting of Forty Fifth RTCA SC-224 Airport Security Access Control Systems Plenary.
Sixteenth Meeting of the RTCA Tactical Operations Committee
The FAA is issuing this notice to advise the public of the Sixteenth Meeting of the RTCA Tactical Operations Committee.
Mine Safety and Health Administration
Section 101(c) of the Federal Mine Safety and Health Act of 1977 and Title 30 of the Code of Federal Regulations Part 44 govern the application, processing, and disposition of petitions for modification. This notice is a summary of petitions for modification submitted to the Mine Safety and Health Administration (MSHA) by the parties listed below.
Petitions for Modification of Application of Existing Mandatory Safety Standards
Section 101(c) of the Federal Mine Safety and Health Act of 1977 and Title 30 of the Code of Federal Regulations Part 44 govern the application, processing, and disposition of petitions for modification. This notice is a summary of petitions for modification submitted to the Mine Safety and Health Administration (MSHA) by the parties listed below.
Agency Information Collection Activities: Information Collection Revision; Submission for OMB Review; Diversity Self-Assessment Template for OCC-Regulated Entities
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a revised information collection, as required by the Paperwork Reduction Act of 1995 (PRA). The OCC may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC previously received OMB approval for a voluntary information collection in the Final Interagency Policy Statement Establishing Joint Standards for Assessing the Diversity Policies and Practices of Entities Regulated by the Agencies (Policy Statement). The OCC now is soliciting comment on a revised information collection which adds a ``Diversity Self-Assessment Template for OCC-Regulated Entities'' (Template) to facilitate the self-assessment described in the Policy Statement. The OCC also is giving notice that it has sent the collection to OMB for review.
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